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About the role:

We are seeking a **Senior Validation Test Engineer** to support a critical initiative focused on validating software installed on laboratory instrumentation in accordance with EMA guidelines. The ideal candidate will have strong Instrument / Medical device validation experience and will be crucial to ensure compliance, documentation accuracy, and alignment with the internal SOPs. You will be a valued member of the Quality & Compliance team and work collaboratively with cross-functional stakeholders including IT, QA, and lab operations to support a critical validation initiative.

**Job Title:** Senior Validation Test Engineer (Instrument/Medical Device)

**Location:** Highland Heights, Kentucky, USA

What you must have to be considered:

+ **8+ years of extensive experience in instrument or medical device validation within a regulated (GxP) environment.**

+ Strong technical writing skills for documentation and test case development.

+ Excellent communication skills to interact with cross-functional teams.

+ Highly detail-oriented with a focus on compliance and accuracy.

+ Familiarity with EMA guidelines and IT SOPs in pharmaceutical or medical device settings.

+ Experience with risk assessment methodologies and validation lifecycle documentation.

These will help you stand out:

+ Prior experience in lab instrumentation software validation is highly desirable.

Work model:

At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance though our various wellbeing programs **. Based on this role’s business requirements, this is an onsite position requiring 5 days a week in a client or Cognizant office in** **Highland Heights, KY.**

**Note:** The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements. Rest assured; we will always be clear about role expectations.

In this role, you will:

+ Document and validate software installed on lab instruments per EMA regulatory standards.

+ Migrate instrument software management to align with PPD IT SOPs.

+ Capture and document software requirements and configurations.

+ Develop validation test cases and protocols related to Instruments/Medical devices validation.

+ Conduct testing and validation of medical devices, including performance testing, reliability testing, and safety testing, to ensure they meet quality standards.

+ Prepare and maintain documentation, including technical specifications, test protocols, validation reports, and regulatory submissions, as required by regulatory bodies and quality management systems.

+ Create infrastructure and data flow diagrams.

+ Conduct comprehensive risk assessments.

+ Collaborate with cross-functional teams including IT, QA, and lab operations.

We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.

Benefits:

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

Medical/Dental/Vision/Life Insurance

Paid holidays plus Paid Time Off

401(k) plan and contributions

Long-term/Short-term Disability

Paid Parental Leave

Employee Stock Purchase Plan

Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.